UnknownNot Applicable

Advanced Cognitive Stimulation Therapy (ACST)

32 participantsStarted 2021-03-01

Plain-language summary

This study is a feasibility randomised controlled trial (RCT) for an evidence-based intervention for people with moderate to severe dementia. The psychosocial intervention is adapted from Cognitive Stimulation Therapy (CST) and developed within the Medical Research Council (MRC) framework.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥ 18
. Diagnosis of dementia, according to the DSM-IV
. SMMSE ≤ 12
. Ability to communicate in English
. Ability to complete outcome measures
. Not having major physical illness or disability that affects participation
. Consultee is willing and able to provide written informed consent if the participant is not able to provide consent.
. Ability to remain in a group for around an hour (e.g. no challenging behaviour)

Exclusion criteria

. Illness and disability that affects participation (as deemed by the researcher or attending care home staff)
. SMMSE \< 5
. Participation in other psychosocial intervention studies

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recruitment (feasibility of ACST)

Timeframe: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years

Retention rate (feasibility of ACST)

Timeframe: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years

Negative or adverse events (acceptability of ACST)

Timeframe: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years

Intervention fidelity (acceptability of ACST)

Timeframe: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years

Intervention fidelity (acceptability of ACST)

Timeframe: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years

Trial details

NCT IDNCT04550975

SponsorUniversity College, London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-01

Contact for this trial

Esther K Hui, BSc

+447460285290 esther.hui.19@ucl.ac.uk

View on ClinicalTrials.gov More DEM trials

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥ 18
. Diagnosis of dementia, according to the DSM-IV
. SMMSE ≤ 12
. Ability to communicate in English
. Ability to complete outcome measures
. Not having major physical illness or disability that affects participation
. Consultee is willing and able to provide written informed consent if the participant is not able to provide consent.
. Ability to remain in a group for around an hour (e.g. no challenging behaviour)

Exclusion criteria

. Illness and disability that affects participation (as deemed by the researcher or attending care home staff)
. SMMSE \< 5
. Participation in other psychosocial intervention studies

What they're measuring

Recruitment (feasibility of ACST)

Timeframe: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years

Retention rate (feasibility of ACST)

Timeframe: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years

Negative or adverse events (acceptability of ACST)

Timeframe: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years

Intervention fidelity (acceptability of ACST)

Timeframe: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years

Intervention fidelity (acceptability of ACST)

Timeframe: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years